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MK-8189 for Bipolar Disorder

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of receiving and tolerating antipsychotic medication within the usual dose range employed for bipolar I disorder
Be between 18 and 65 years old
Must not have
History of cancer (malignancy)
Major surgery or donation/loss of 1 unit of blood within 4 weeks prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~28 days

Summary

This trial aims to assess how safe and well-tolerated MK-8189 is in individuals with stable bipolar I disorder. The study will not involve testing specific hypotheses.

Who is the study for?
This trial is for adults with a stable form of bipolar I disorder, who have previously tolerated antipsychotic medication. Participants must have a body mass index between 18 and 40 kg/m^2 and can discontinue current antipsychotics at least 5 days before the study starts.
What is being tested?
The study is testing MK-8189, a potential treatment for bipolar I disorder. It will compare the effects of MK-8189 against a placebo (a substance with no active drug) to assess its safety and tolerability in participants.
What are the potential side effects?
Since this trial aims to evaluate safety, specific side effects are not listed but may include typical reactions to psychiatric medications such as drowsiness, weight changes, dry mouth, restlessness or digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have taken and tolerated antipsychotic medication for bipolar I disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had cancer before.
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I haven't had major surgery or donated/lost a significant amount of blood in the last month.
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I have had severe reactions to antipsychotic drugs.
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I have a seizure disorder or take medication to prevent seizures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Who Discontinue Study Treatment Due to an AE
Number of Participants Who Experience One or More Adverse Events (AEs)

Side effects data

From 2018 Phase 2 trial • 224 Patients • NCT03055338
18%
Weight increased
13%
Sedation
11%
Headache
9%
Dizziness
9%
Akathisia
9%
Nausea
7%
Fatigue
7%
Dyspepsia
7%
Lethargy
7%
Agitation
4%
Schizophrenia
4%
Somnolence
2%
Decreased appetite
2%
Vomiting
2%
Anxiety
2%
Alcohol poisoning
100%
80%
60%
40%
20%
0%
Study treatment Arm
Risperidone
MK-8189
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Panel C: MK-8189 Dosing Regimen 3Experimental Treatment1 Intervention
Participants will receive MK-8189 QD at dosing regimen 3 for up to 14 days.
Group II: Panel B: MK-8189 Dosing Regimen 2Experimental Treatment1 Intervention
Participants will receive MK-8189 QD at dosing regimen 2 for up to 14 days.
Group III: Panel A: MK-8189 Dosing Regimen 1Experimental Treatment1 Intervention
Participants will receive MK-8189 once daily (QD) at dosing regimen 1 for up to 14 days.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive MK-8189-matching placebo QD for up to 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-8189
2020
Completed Phase 2
~680

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,986 Previous Clinical Trials
5,178,825 Total Patients Enrolled
4 Trials studying Bipolar Disorder
1,312 Patients Enrolled for Bipolar Disorder
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,868 Previous Clinical Trials
8,082,754 Total Patients Enrolled
9 Trials studying Bipolar Disorder
2,098 Patients Enrolled for Bipolar Disorder
~23 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
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